LogoFDA 510(k) Search
K Number
K971718
Device Name
MICRO-SEAL ACETABULAR SYSTEM
Manufacturer
WHITESIDE BIOMECHANICS, INC.
Date Cleared
1997-07-23

(75 days)

Product Code
LPH
Regulation Number
888.3358
Type
Traditional
Panel
OR
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This device is intended to be used for:

  • noninflammatory degenerative joint disease including 1. osteoarthritis and avascular necrosis
  • rheumatoid arthritis, 2.
  • correction of functional deformity, 3.
  • revision procedures where other treatments or devices have 4. failed,
    1. treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
Device Description

This implantable device consists of a generally hemispherical shape titanium shell with six screw holes for optional additional fixation with bone screws. A UHMWPE modular liner is pressed or tapped into the shell. Push out resistance of the polyethylene is attained by the interlocking geometry of the shell. Rotational fixation is obtained by tabs located on the liner that mate with notches on the shell. Toggle fixation is achieved with the nub on the backside The inner surface of the of the liner fitting into the driver hole through the shell. polyethylene articulates with the spherical portion of the femoral component.

AI/ML Overview

The provided document is a 510(k) summary for the Whiteside Biomechanics Micro-Seal Acetabular System. It describes the device, its intended use, and confirms substantial equivalence to pre-amendment devices for market clearance. However, it does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

Specifically, the document focuses on:

  • Device Description: Material, design, and components of the acetabular shell.
  • Intended Use: Clinical conditions for which the device is indicated (e.g., osteoarthritis, rheumatoid arthritis, revision procedures).
  • Sterilization: Details about the sterilization method (EtO), sterility assurance level (10^-6), and the sterilizer used.
  • Regulatory Clearance: The FDA's 510(k) clearance letter, confirming substantial equivalence and the product code.
  • Postmarket Surveillance: Mandate for a Section 522(a) postmarket surveillance study for this device, including submission of a protocol and principal investigator's profile.

No information is present in this document regarding:

  1. Acceptance criteria for performance (e.g., mechanical strength, wear rates, biocompatibility), or specific quantitative thresholds the device needed to meet.
  2. Reported device performance data from a study against any acceptance criteria.
  3. Sample size for any test set or the data provenance.
  4. Number of experts for ground truth, their qualifications, or adjudication methods.
  5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
  6. Standalone (algorithm-only) performance.
  7. Type of ground truth used.
  8. Training set sample size or how ground truth for training was established.

The document is purely regulatory in nature, indicating FDA clearance based on substantial equivalence, and outlining post-market requirements. It does not provide any technical study results or performance data against specific acceptance criteria.

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.